Lilly factory in New Jersey comes under more federal scrutiny
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A factory in New Jersey belonging to Indianapolis-based drugmaker Eli Lilly and Co. has run into more manufacturing problems during a federal inspection.
The factory racked up eight deficiencies during an inspection last year by federal investigators, according to a Jan. 19 report by Reuters, which obtained government records under a freedom of information request.
The deficiencies included problems in tracking manufacturing process and quality controls, as well as lapses in calibration of equipment and failure to properly maintain facilities and equipment, Reuters said.
The factory makes migraine treatment Emgality, diabetes medicine Trulicity and cancer treatments Erbitux and Cyramza. Trulicity has been Lilly’s top-selling drug since 2018.
The problems are the latest in a string of deficiencies uncovered at the plant by Reuters. Earlier issues include failure to track potentially contaminated drug batches that were supposed to be inspected by the company’s quality-control unit, unknown debris in a production area and that raw drug ingredients produced there were not adequately controlled.
In an email to IBJ, Lilly said the inspection followed a company request to manufacture the migraine drug Emgality, also known by its generic name galcanezumab, at the plant, located in Branchburg, New Jersey.
The inspection resulted in “some observations that were, in most cases, either addressed during the inspection or already in progress as program improvements,” Lilly said.
“We continue to work closely with the FDA,” Lilly’s statement continued. “Importantly, this situation does not affect the quality, safety or supply of any current or planned Lilly products in the marketplace.”
About five years ago, a former human resources officer for Lilly at the plant sued the drugmaker, claiming she was terminated after pointing out poor manufacturing practices and data falsification.
The officer, Amrit Mula, said she repeatedly urged senior Lilly officials, contended she was fired in 2019 in retaliation for investigating employee complaints about drug manufacturing problems.
She brought her complaint as a whistleblower and accused the Indianapolis-based drugmaker of retaliating against her in violation of New Jersey’s Conscientious Employee Protection Act.
That law prohibits employers from taking retaliatory personnel action against an employee who refuses to participate in any activity that the employee believes is in violation of the law. The matter has since been resolved and Mula agreed to dismiss the case in September 2023.
“Lilly has at all times denied the allegations made by the plaintiff in this matter, and the resolution of the matter in no way admits any wrongdoing,” Lilly told IBJ.
In May 2021, Lilly received a subpoena from the U.S. Department of Justice requesting the production of certain documents relating to the factory. Lilly said in a government filing it was cooperating fully with the investigation. That investigation is ongoing.